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Association of Mean Platelet Volume and Cardiovascular Disease in Children With End Stage Renal Disease.

Association Between Mean Platelet Volume With Echocardiographic Indices and Carotid Intima Media Thickness in Children With End Stage Renal Disease.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03759002
Enrollment
102
Registered
2018-11-29
Start date
2016-02-01
Completion date
2018-06-15
Last updated
2018-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Carotid Intimal Media Thickness, Children, End Stage Renal Disease, Hemodialysis Complication, Left Ventricular Hypertrophy, Mean Platelet Volume, Peritoneal Dialysis Complication

Brief summary

Cardiovascular disease (CVD) is the major risk factor for death in end stage renal diseases (ESRD). Approximately 80% of ESRD patients have some degrees of left ventricular abnormalities at initiation of dialysis. Carotid intima media thickness (CIMT) has been widely accepted as an useful marker to assess CVD in ESRD children. In addition, cardiac mechanics parameters are used to evaluate cardiac function more precisely. However, measuring CIMT and cardiac mechanics parameters are expensive and difficult to perform as a routine method. Mean platelet volume (MPV) is a hematological index which shows the size of platelets. Uremic state causes inflammatory condition that affects MPV. Previous studies on people with normal renal function have shown that this parameter can also have association with CVD. However the data in children with ESRD is scarce. The aim of this study is to find a simple hematologic marker to use regularly in ESRD children finding patients at risk of CVD. Therefore, we will investigate the relationship between mean platelet volume and CIMT and cardiac mechanic parameters in children with ESRD.

Interventions

DIAGNOSTIC_TESTImaging

Imaging including Echocardiography for determining cardiac indices (ejection fraction, left ventricular mass index, strain rate, global longitudinal strain) and Doppler ultrasound for measuring carotid intima media thickness

OTHERBlood sampling

Blood sampling will performed on all participants for measuring hematological parameters including MPV.

Sponsors

Isfahan University of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* Children under 18 years who have being dialyzed (hemodialysis or peritoneal dialysis) regularly more than 6 months, as case group. * Age and gender matched healthy children who have been referred for routine medical examination.

Exclusion criteria

* Patients with uncontrolled hypertension (until being stabled) * Patients on any kind of antithrombotic agents or NSAIDs * Severe obesity * Diabetes patients * Patients with a past history of CVD or stroke in the last 6 months * Passive smokers who contacted daily with high smokers in their houses * Patients with known hematologic diseases or malignancies (such as Fanconi Anemia) * Uncontrolled hypothyroid or hyperthyroid patients * Patients with recent (in the last 4 weeks) catheter or exit -site infection.

Design outcomes

Primary

MeasureTime frameDescription
Correlation between MPV and carotid intima media thickness2 years after study beginningDetermining correlation between the value of MPV with carotid intima media thickness in patients
MPV in patients and controls1 year after study beginningComparing the mean of MPV in patients and controls.
Echocardiographic indices in patients and controls1.5 years after study beginningComparing the means of echocardiographic indices in patients and controls
Carotid intima media thickness in patients and controls2 years after study beginningComparing the mean of carotid intima media thickness in patients and controls
Correlation between MPV and ejection fraction1.5 years after study beginningDetermining correlation between the value of MPV with ejection fraction in patients
Correlation between MPV and left ventricular mass index1.5 years after study beginningDetermining correlation between the value of MPV with left ventricular mass index in patients
Correlation between MPV and strain rate1.5 years after study beginningDetermining correlation between the value of MPV with strain rate in patients
Correlation between MPV and global longitudinal strain1.5 years after study beginningDetermining correlation between the value of MPV with global longitudinal strain in patients

Secondary

MeasureTime frameDescription
MPV and thrombotic events2 years after study beginningComparing the values of MPV in patients with and without previous histories of thrombotic events including arteriovenous fistula thrombosis, cerebrovascular accident, deep venous thrombosis, and cerebrovascular accident

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026